Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
510(k) Number K121173
Device Name CHORD-X EPTFE SUTURE
Applicant
On-Xlifetechnologies
1300 E. Anderson Lane
Bldg. B
Austin,  TX  78752
Applicant Contact JOHN ELY
Correspondent
On-Xlifetechnologies
1300 E. Anderson Lane
Bldg. B
Austin,  TX  78752
Correspondent Contact JOHN ELY
Regulation Number870.3470
Classification Product Code
PAW  
Date Received04/17/2012
Decision Date 08/16/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-